# K945271: Atac 8000 Random Access Chemistry System

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Chem Laboratory Systems, Inc.
- Decided: Apr 20, 1995 after 184 days
- Product code: JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2160
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K121027: Diamond Calibrator Low, Diamond Calibrator High (2012), 1 descendant of its own
- K133751: Diamond Diagnostics Ise Serum Standards, Diamond Diagnostics Ise Urine Standards (2014), 0 descendants of its own

## Recalls of this device
- Apr 18, 2017 · Class II · Z-2591-2018: ELITech Clinical Systems SAS initiated this recall because some users of ENVOY 500 ISE CALIBRATOR Kit (Part number: 55117), for Envoy 500 systems are observing trouble while calibrating with some vial

Source page: https://510kreport.com/device/K945271
Methodology: https://510kreport.com/methodology